Case Study

Replacing An Existing Paper-Based GMP Record System And Manual Process With An Electronic Monitoring System To Comply With FDA 21 CFR Part 11

Goals

To replace an existing paper-based GMP record system and manual process with an electronic monitoring system

Challenges

A significant amount of time is spent each day manually reviewing reports

The existing paper-based system was time-consuming and vulnerable to reporting errors

A new system must enable the company to remain in compliance with federal regulations

Results

The electronic initiative helps produce 75 million tests

The equipment monitoring system saves about 1,100 man hours per year

The data reviewing time is reduced from 15+ hours to just minutes

Electronic monitoring saves 2/3 of time, or about 10 hours per month in quality assurance

Being in the life sciences industry, Fujirebio adheres to a strict manufacturing process.

These processes are certified with compliance for reporting and documentation requirements that are very detailed and extensive.

With a more than 20-year reputation as a trusted source of innovative solutions in clinical diagnostics, Fujirebio Diagnostics, Inc.’s proven manufacturing process for the production of biomarkers has made it a global partner of choice among leading diagnostics companies around the world. Being in the life sciences industry, Fujirebio adheres to a strict manufacturing process. The biomarkers produced by Fujirebio help physicians, lab professionals and patients better manage disease.

“The biomarkers manufactured by Fujirebio are basically blood tests, and our core competency is in oncology. The products which we have intellectual property for are mainly centered on cancer testing,” said Mike Koch, vice president of supply chain at Fujirebio.

An Extensive Array of “Gold Standard” Biomarkers for Oncology

Over the course of the year, Fujirebio’s 160,000-foot production facility produces about 75 million tests that are distributed throughout the world. It is a FDA-registered facility that is 21 CFR Part 11 compliant, and is both ISO 9001 and ISO 13485 certified for quality systems.

A major milestone was achieved at Fujirebio on July 1, 2013 when its manual, paper-based process of periodically recording temperature readings for specific manufacturing equipment was officially replaced by a new computerized system.

“At Fujirebio, we are looking to take advantage of our electronic systems,” Koch said. “We installed the equipment monitoring system to electronically capture data from Fujirebio’s temperature-controlled areas. The new monitoring system also provides the company with a scalable infrastructure which we can implement other electronic data capture projects as we go forward.”

Innovation Always Starts with an Idea

The project started when the personnel at the Malvern, Penn. campus identified a major opportunity to save time and paper, while still retaining compliance by automating the acquisition of equipment data and generating electronic reports for review and approval. The solution is called the Electronic Initiative and the first phase of the implementation is called the Equipment Monitoring System, or EMS.

“EMS provides us a way of archiving data and it allows us to trend the way our equipment is operating to make sure its staying within our specifications and up to our standards,” said Josh Zimmer, Fujirebio quality engineer.

The EMS system at Fujirebio performs a number of very important functions such as:

Enabling personnel to monitor equipment from their workstations

Maintaining all temperature readings in electronic records

Notifying authorized personnel in the event of adverse temperature trends

The solution is completely paperless and provides electronic record collection with electronic signatures while maintaining 21 CFR compliance and ISO 9001 and 13485 certification

“Before the EMS system went in, I was spending about 15 or more hours manually reviewing the GMP packs. After the system, I went from hours to minutes,” said Rachael Vinjamuri, lead manufacturing document analyst at Fujirebio. “The key benefits of the system are the electronic signatures with the review by exception, and not having to worry about missing papers or chart recorders. The system has just made my life a whole lot easier.”

Saving Time and Effort with Wonderware

Now that it’s up and running, the employees at Fujirebio have more time to spend on other productive activities.

The new EMS has relieved staff of the tasks related to manually logging equipment parameters and reviewing paper logs and charts on a daily basis. The amount of time saved equates to:

Activity

Time Saved

Logging Data

439 hours

Check Recorder Charts

230 hours

Change Charts

30 hours

Prep & Review Doc Pack

89 hours

Dept. Review Doc Pack

112 hours

QA Review Doc Pack

192 hours

Total:

1,100 hours

“Going paperless has saved us a huge amount of time and it has freed us up to do other aspects of our job,” said Cynthia Travia, Fujirebio quality assurance analyst. “I’m saving approximately two-thirds of my time, or about 10 hours a month, by using the EMS system.”

What makes the solution unique is that it is a complete paperless system with electronic records and electronic signatures. It generates eighteen monthly department reports for review by exception, and routes reports for review and approval via the Wonderware Skelta BPM workflow solution software.

Capabilities for Future Growth

“At Fujirebio we’re looking to take advantage of our electronic systems. We installed the equipment monitoring system to electronically capture data from our temperature controlled areas. But it also provides us with infrastructure for other electronic data capture projects as we go forward,” Koch said.

Wonderware Skelta BPM – the Heart of the EMS at Fujirebio

What Wonderware Skelta BPM does is digitize and automate Fujirebio’s manual processes that include people, equipment and systems, based on a sophisticated Business Process Management (BPM) foundation standard.

Wonderware Skelta BPM is integrated into Wonderware System Platform. The combined functionality of Skelta BPM with Wonderware System Platform enables Fujirebio to model, execute, analyze and improve work processes, enhancing collaboration, productivity, and innovation.

Each day, companies such as Fujirebio execute complex work flows involving both people and systems.

Consistent execution of critical work leads directly to better operating performance. With Wonderware Skelta BPM, Fujirebio is able to route critical reports for review and approval, ensuring that vital work flows are executed correctly every time. This drives accountability and better stewardship within the organization.

“With Wonderware Skelta BPM, our staff is able to generate electronic records and then file them automatically,” said Ken Kovacs quality business systems manager at Fujirebio. “Perhaps the key business metric of the EMS is the time saved as a result of going paperless, which is especially important in a regulated industry.

With Wonderware Skelta BPM, Fujirebio is able to comply with 21 CFR Part 11 for electronic records and electronic signatures.”

Skelta BPM also enables Fujirebio staff to successfully model entire work flows involving people and systems, as well as the proper task sequencing and dependencies. The application tracks each work step and records the outcome so Fujirebio staff has the detail it needs to properly evaluate work performance and fine tune work flows. Overall, Skelta BPM improves operational consistencies at Fujirebio, and in turn enhances productivity and reduces operational costs.

“The largest benefit of the equipment monitoring system is that we are logging automatically now rather than manually, so it’s saving us about 1,100 man hours per year,” Zimmer said. “In addition to the benefits that Fujirebio now gets from EMS, the real advantage is what it can do in the future.

Because of the way the system is architected, Fujirebio now has the flexibility to expand to other types of applications such as process automation, MOM/MES, operations improvement and ERP integration. The scalability of the solution will sustain all the innovation and future projects.

The future looks bright for Fujirebio as it continues to help healthcare professionals and patients manage disease. Every day, thousands of people all over the world are living a better life because of the products Fujirebio manufactures. With the help of Wonderware, Fujirebio is sure to remain a trusted source of innovative clinical diagnostics solutions for another 20 years.

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